Restoring Study 329: Letter to BMJ

Jon Jureidini, MD
6
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When we set out to restore GSK’s misreported Study 329 of paroxetine for adolescent depression under the RIAT initiative, we had no idea of the magnitude of the task we were undertaking. Although GSK eventually agreed after protracted correspondence to release Individual Patient level data, they did so in a way that slowed and limited our analysis.

After almost a year, we were relieved to finally complete a draft and submit it to the BMJ, who had earlier indicated an interest in publishing our restoration. But that was the beginning of another year of peer review that we believed went beyond enhancing our paper and became rather an interrogation of our honesty and integrity. David Healy and I were the main focus of accusations that conflicts of interest made us unreliable. In the end our analysis of adverse events was subject to an ‘independent’ audit by a BMJ-appointed scientist, a process that to our knowledge is unprecedented. Our analysis was found to be sound. Frankly, we were offended that our work was subject to such checks when papers submitted by pharmaceutical companies with fraud convictions are not.

We could see where BMJ were coming from, being fearful of litigation and the power of GSK, but in our view they handled it tactlessly, and if weren’t for mediation provided by Peter Doshi, associate editor of the BMJ and first author of the RIAT paper, our paper would never have been published by them.

So with all this vexation, we were bemused to find, quite by accident, that our BMJ editor, Dr Elizabeth Loder, had a level of direct and indirect engagement with GSK that seemed to us to far outweigh any perceived COI that we may have had.

We took this up with BMJ as follows: ​

8 July 2015

Dr Fiona Godlee
Editor
BMJ

Dear Dr Godlee

Re: “Restoring Study 329: A randomised, controlled trial of the efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression”

I note your earlier comment about BMJ’s risks being ‘more editorial than legal’. Coincidentally when we were looking up Dr Elizabeth Loder’s profile in relation to her concerns about our handling of headache in our adverse events analysis, we became aware of a potential conflict of interest.

BMJ staff have understandably been very careful about any perceived conflict of interest on the part of our team, given that some of us have previously criticized GSK’s Study 329; we now have concerns about Dr Loder’s indirect but significant links with GSK.

  • Her hospital (Brigham and Women’s) received over $12 million in research funding from GSK in 2014, up from just over $100,000 in 2003

(https://openpaymentsdata.cms.gov/company/100000005449).

  • Dr Loder has made public statements favourable to GSK products, including: ‘For all of these reasons my mantra is that “You haven’t failed sumatriptan until you have failed to respond to a full dose of injectable sumatriptan given early in an attack!” There is also evidence that combining a triptan with an anti-inflammatory drug might improve the likelihood it will be effective’.

(http://live.washingtonpost.com/how-serious-are-migraines.html ). This article was published just before GSK’s Treximet (combination triptan and anti-inflammatory) came on to the market.

  • Dr Loder’s husband, John M. Loder, is a partner in Ropes & Gray, a law firm retained by GSK in the US Department of Justice’s action against them, in which Study 329 was a central element

(http://www.law360.com/articles/250821/how-they-won-it-steptoe-gets-rare-acquittal-for-gsk-atty ).

More recently, the law firm has supported GSK with its difficulties in China

(http://www.legalweek.com/legal-week/news/2284819/ropes-gray-takes-lead-role-on-gsk-probe-into-china-bribery-claims).

Although, as Dr Loder’s COI declaration at BMJ points out, John Loder’s work is not in the healthcare field, as a partner in Ropes & Gray, he presumably profits directly from such work.

We believe that Dr Loder’s interests have been incompletely declared and that it might have been appropriate for her to recuse herself from involvement in the assessment of our paper to avoid any perception that GSK’s interests were being considered in BMJ’s deliberations.

While the timing for bringing these concerns to your attention is not ideal, we wanted to inform you as soon as possible after we became aware of these potential conflicts.

I look forward to hearing from you soon.

Yours sincerely

Jon Jureidini
On behalf of the RIAT 329 group

With thanks to DavidHealy.org for the
initial publication of this letter, and the photos.

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6 COMMENTS

  1. Jon,
    As you probably know more than you let on here, you should not expect any honesty from these pawns of Big Pharma: Big Pharma companies and those it sponsors operate as a legalized cartel, caring only about profits, and always willing to distort, subvert, and outright lie about the facts, whether or not it hurts their patients. Peter Gotszsche has already exposed these practices well in his books, like Psychiatry and Organized Crime.

  2. I am saddened how individuals such as Dr Fiona Godlee, seduced by money,power, and status, fail to see how deeply embedded they are in a system that puts profit above people, resulting in their dereliction of duty to protect those they are sworn to protect. I am also saddened how corporations use people’s fear of economic loss and lowered status to their advantage, effectively keeping the majority of professionals silent on the issue of corruption and false or misleading data. The pursuit of justice and truth can be a lonely, solitary road that very few are willing to embark upon.

    Thank you for exposing this false data through this restored study. I hope that you and the other authors of the restored study 329 experience peace of mind for using your education for the greater good, despite the fact that you have been subjected unfairly to a double standard.

    • This is, unfortunately, the core value of American neo-conservatism. To the Big Time Authorities and the double-dippers, YOU are what’s wrong with 21st century health care and you’d be a happy camper, if only you’d get on the Big Bandwagon and enjoy the ride- those patients are just a bunch of malingering misfits, anyway, so they should be happy to be no trouble as 21st century zombies.

  3. I wish a special place in Hell for people who profit from the pharma-drug abuse of children.

    The work the authors took on should have been lauded from the beginning, not something they had to fight to do and to have accepted.

    Shame on psychiatry and conventional medicine. The harm done to children by these drugs makes me sick.

    Liz Sydney

  4. Recently, I had a Dr.’s appointment…. I brought a 3-page print-out of an article I found online, about “Study 329”. (Sorry I can’t recall exactly *which* article – maybe one from MIA? But anyway, it was VERY critical, and well-written.) I asked my Dr. if he’d heard of “Study 329”. He hadn’t. I gave him the article, and told him to educate himself. A few days later, I received a “Termination of Medical Care” email from the hospital. Basically, I was “fired” as a patient for speaking out on Study 329! I was on imipramine for a few years in my late teens, early 20’s….
    Thank-you, Dr. Jureidini. please understand that what you do sometimes has REAL effects on REAL people out here in limbo…..(I’m pretty sure you were NOT involved in the article I mentioned here….)….
    What’s the latest with the Garth Daniels’ forced drugging & Electrocution Torture(“ect”) case?